Recast

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09 Nov 2015,
Erik Vollebregt
The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December….

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06 Nov 2015,
Erik Vollebregt
In March 2014 Gert Bos (Head of Regulatory and Clinical Affairs at notified body BSI) and I wrote a white paper on the new EU medical devices and IVD regulations in the legislative procedure….

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26 Oct 2015,
Erik Vollebregt
White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the…

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21 Jun 2015,
Erik Vollebregt
Yes we can! We have a general approach for both the Medical Devices Regulation and for the IVD Regulation, agreed in the EPSCO Council last Friday. The press release also conveniently bundles…

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16 Jun 2015,
Erik Vollebregt
Upon closer examination of the two texts for the MDR and IVDR it became clear that the scrutiny proposals in both regulations are actually identical (sorry for the earlier confusion). Accordingly, there are…

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16 Jun 2015,
Erik Vollebregt
As promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council. In this post I will…

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03 Jun 2015,
Erik Vollebregt
To get unstuck or not to get unstuck, that is the question that hangs over the medical devices regulation dossier in the Council currently. EPSCO council 18/19 June With the Latvian presidency…